The goal of this clinical trial is to evaluate whether an opioid-sparing postoperative pain regimen can reduce opioid consumption and maintain effective pain control in adults undergoing anterior total hip arthroplasty for osteoarthritis. The main questions it aims to answer are: * Does an opioid-limited regimen result in lower postoperative opioid use compared with a standard opioid prescription? * Does the opioid-limited regimen provide comparable or improved postoperative pain control and patient satisfaction?
This study evaluates whether an opioid-sparing postoperative regimen can reduce opioid use while maintaining effective pain control in adults undergoing anterior total hip arthroplasty for osteoarthritis. Although opioids are commonly used after joint replacement, they carry risks such as side effects and long-term dependence. Multimodal analgesic strategies-using combinations of non-opioid medications and local anesthetic techniques-have shown promise in reducing opioid requirements while providing adequate pain relief. All participants in this randomized, double-blind trial will receive a standardized multimodal non-opioid pain regimen throughout the perioperative period, along with counseling from a Life Care Specialist. Participants will be assigned to receive either a standard opioid prescription or placebo tablets at discharge, with a small supply of rescue hydromorphone available for severe breakthrough pain. Pain scores, nausea, opioid consumption, and patient-reported outcomes will be collected during the first postoperative week and at follow-up visits at 3 weeks and 3 months. The study aims to determine whether limiting routine opioid prescribing after hip arthroplasty can safely reduce opioid exposure without compromising recovery or patient satisfaction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
* 28 tablets identical in appearance to 5-mg oxycodone * Taken 1-2 tablets every 4 hours as needed for moderate to severe pain * Dispensed by Investigational Drug Services * Used in combination with standardized multimodal analgesia
* 28 tablets of 5-mg oxycodone * Taken 1-2 tablets every 4 hours as needed for moderate to severe pain * Represents standard postoperative prescribing practi
Multimodal Non-Opioid Analgesia (Standardized Regimen) Includes: * Acetaminophen * Meloxicam * Methylprednisolone taper * Spinal anesthesia * Periarticular local anesthetic injection * Postoperative scheduled acetaminophen and NSAIDs * Counseling by Life Care Specialist * Two 2-mg hydromorphone tablets for rescue only
Emory University Orthopedics and Spine Hospital
Atlanta, Georgia, United States
RECRUITINGDaily Pain Scores (Numeric Rating Scale, NRS)
A 0-10 numeric scale used to assess pain intensity. Participants rate their pain three times daily during the first postoperative week. Mean daily pain scores will be compared between groups. High scores: greater pain intensity. Low scores: better pain control.
Time frame: Postoperative Days 1-7
Opioid Consumption (Morphine Milligram Equivalents, MME)
Total opioid use, including study medication, rescue hydromorphone, and any additional prescriptions, will be converted to MME to quantify postoperative opioid consumption.
Time frame: 1 week, 3 weeks, and 3 months postoperatively
Pain-Related Contacts to Clinical Team
Number of calls or electronic messages to the surgical team related to pain management.
Time frame: Up to 3 months postoperatively
Medication-Related Side Effects
Incidence and severity of nausea, constipation, vomiting, or other adverse effects associated with postoperative pain medications.
Time frame: Postoperative Days 1-7
Opioid Prescription Refills
Number of opioid prescription refills requested or obtained after surgery.
Time frame: Up to 3 months postoperatively
Patient Satisfaction With Pain Control
Patient-reported satisfaction with postoperative pain control, rated on a 5-point scale (much worse than expected to much better than expected).
Time frame: 1 week, 3 weeks, and 3 months
Patient-Reported Outcomes (PROMs): HOOS Jr
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Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS Jr.): A validated 6-item questionnaire assessing hip pain and functional ability in patients undergoing hip arthroplasty. 0-100 (converted score) Interpretation: * Higher scores indicate better hip function and less pain. * Lower scores indicate greater disability or worse symptoms.
Time frame: Baseline (preoperative) and at 3 months
Patient-Reported Outcomes (PROMs): EQ-5D (EuroQol-5 Dimensions)
A standardized measure of health-related quality of life across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Includes a health VAS. Index values typically 0-1 High scores: better overall health status. Low scores: poorer health or greater impairment.
Time frame: Baseline (preoperative) and at 3 months
Patient-Reported Outcomes (PROMs): Subjective Hip Value (SHV)
A single-item measure in which patients rate their hip function as a percentage of normal. * 0% = Completely nonfunctional hip * 100% = Completely normal hip Interpretation: * Higher percentages indicate better perceived hip function. * Lower percentages indicate worse perceived function.
Time frame: Baseline (preoperative) and at 3 months
Patient-Reported Outcomes (PROMs): Pain Catastrophizing Scale (PCS)
A 13-item questionnaire assessing catastrophic thinking related to pain (rumination, magnification, helplessness). Used at baseline for eligibility. Score range 0-52 High scores: greater pain catastrophizing; scores \>29 indicate high catastrophizing. Low scores: minimal catastrophic thinking.
Time frame: Baseline (preoperative) and at 3 months
Postoperative Nausea (VAS-Nausea)
Nausea severity recorded three times daily using a 0-10 Visual Analog Scale. A 0-10 scale used to measure severity of postoperative nausea. Recorded three times daily for 7 days. High scores: more severe nausea. Low scores: minimal or no nausea.
Time frame: Postoperative Days 1-7
Sleep Quality and Pain-Related Satisfaction
A patient-reported measure assessing perceived sleep quality and satisfaction with pain management during the study period. Both items use a 0-10 Numeric Rating Scale (NRS). * Higher scores indicate better sleep quality and greater satisfaction with pain management. * Lower scores indicate poorer sleep quality and lower satisfaction.
Time frame: Postoperative Days 1-7
Length of Stay (LOS)
Duration of postoperative hospitalization.
Time frame: Day of surgery through discharge (usually upto 7 days)
Healthcare Utilization
Number of emergency department visits, readmissions, and reoperations related to the index surgery.
Time frame: Up to 3 months postoperatively